Aptahems drug candidate Apta-1 targets several key factors in sepsis with the goal of reducing inflammation and restoring balance to the immune system. Sepsis is a serious condition that starts with an overactive immune response to an infection, which can lead to multiple organ failure and death.
The ongoing Phase I clinical study is divided into two parts: Phase Ia and Phase Ib. During the spring, the company has conducted four cohorts in Phase Ia. In the upcoming Phase Ib study, the company intends to evaluate the effect of Apta-1 on a provoked inflammatory response in healthy volunteers. Phase Ib aims to minimize the risk ahead of the upcoming Phase II study. This will examine the effect of Apta-1 in patients.
CEO comments on the paused study
Aptahem has previously aimed to complete the Phase Ia study in the summer of 2023, followed by a Phase II study next year and a pivotal Phase III study in 2026.
However, on July 17, the company announced that it had made 'interesting findings' in the Phase Ia study, and after the Data Review Committee reviewed these data, the committee recommended that Aptahem perform further analyses. As a result, the study has now been temporarily paused.
To learn more about the observed data that led to the study being paused, BioStock contacted Aptahem's CEO. Mikael Lindstam for a comment.
Mikael, can you elaborate on what kind of interesting findings you have made?
– In analyses performed during the course of the study with dose escalation in cohorts 1 to 4, these have shown signs that Apta-1 affects more markers than we have seen in previously performed animal experimental studies. Since safety comes first in clinical studies, the committee has therefore recommended that we investigate these further to gain as thorough an understanding as possible of how Apta-1 works in humans. We see this as an opportunity to understand and explain more aspects of how our drug candidate's mechanism of action works.
Do you believe that there are no potentially negative effects of Apta-1 that could jeopardize the candidate being given to patients in the future?
– After each completed cohort in the study, the authorities and the ethics committee have reviewed the results to ensure that it has been safe to continue to the next cohort. Because we are breaking new ground with Apta-1 with the new and complex mechanism and its effect, things emerge that we could not know. The regulatory authorities also do not have much experience with the type of substance that Apta-1 is. Therefore, more in-depth knowledge of Apta-1 in humans is needed and so far we do not see anything to indicate that it could jeopardize any further studies on patients in the future.
How long do you estimate the further analyses will take and will this affect your timelines for future development?
– We are working with our CRO to carry out the analyses and they in turn have sub-consultants for the various specific parts of this work. It is also summer and holiday time now, which means that we do not dare to give any time estimates. The only thing I can say is that this is a high priority and everyone is working as fast as they can.
Finally, can you describe your overall strategy to ensure successful commercialization of Apta-1?
– Our strategy is to conduct the early clinical studies with Apta-1 in a strategic, safe and cost-effective manner to ensure and offer as complete a project as possible for a future license partner. With this future partner and its capacity, our goal is to reach the market together to be able to improve and save the lives of many patients. An example of how we work strategically is the planned phase Ib study where we can see the effect at an early stage and also identify the optimal dose level for the phase II study.